Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas. (SPIDER-MEN)

High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.

Study Overview

• Status: Recruiting
• Conditions: Meningioma
• Intervention / Treatment: Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorenzo Vinante; Phone Number: 0434 659855; Email: lorenzo.vinante@cro.it
• Study Contact Backup: Name: Maurizio Mascarin; Email: mascarin@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico di Aviano (CRO)
      • Principal Investigator: Maurizio Mascarin, MD
      • Contact: Lorenzo Vinante, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 16 years;
• Ability to express appropriate informed consent to treatment;
• Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;
• In case of recurrence, confirmation can be either histological or radiological;
• Not previous brain-level radiotherapy;
• Performance status: ECOG=0-2.

Exclusion Criteria:

• Refusal to radiation treatment (i.e., absence of signed informed consent);
• Other concomitant oncologic therapies
• Current pregnancy;
• Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;
• Inability to perform MRI with MoC or PET.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging; Radiation treatment with higher doses than the standard and defined using PET imaging	Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging; Radiation treatment with higher doses than the standard and defined using PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of brain radionecrosis	Incidence of symptomatic brain radionecrosis (grade >=2 defined according to CTCAE scale v5.0).	up to 13 years
Assess progression free survival (progression free survival = PFS) at 3 years	Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)	up to 13 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (Overall survival = OS)	Overall survival (OS) will be defined as time between enrollment and death	up to 13 years
Incidence of other toxicities	Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0	up to 13 years
Concordance between GTV-RM and GTV-PET	Concordance will be measured according to Dice Similarity coefficient	up to 13 years

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Lorenzo Vinante, Centro di Riferimento Oncologico di Aviano (CRO)

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): December 23, 2037
• Study Completion (Estimated): December 23, 2037

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Somatostatin
• Other Study ID Numbers: CRO-2024-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No